Mundipharma Research Ltd Job Description JOB TITLE: Senior Scientist Pharmaceutical Operations Grade 1 and Grade 2 SECTION: DEPARTMENT: Technical Support COMPANY: Mundipharma Research Ltd RESPONSIBLE TO: Head of Technical Support A. DATE: Pharmaceutical Operations June 2013 BROAD PURPOSE OF JOB To support the activities of the Technical Development (TD) Directorate by managing the procurement, receipt storage, dispensing, issue, dispatch, return and destruction of materials and products used in formulation and process development of a range of pharmaceutical products by Pharmaceutical Development. To support the activities of the TD Directorate by managing the receipt, storage, dispensing, issue, dispatch of bulk materials and destruction of materials and products used by the Clinical Supplies Department for Clinical Studies. To support the activities of the TD Directorate by managing, the equipment and facilities used in formulation, process development and clinical trial supplies. B. SPECIFIC DUTIES AND RESPONSIBILITIES 1. Manage the procurement, approval, control, storage and dispensing of materials to support the pharmaceutical development projects within the appropriate timelines. 2. Manage the receipt, approval, control (in conjunction with Clinical Supplies), storage and dispensing of materials to support Clinical Supplies studies within the appropriate timelines. 3. Co-ordinate the supply of materials for required project work/Clinical Studies and ensure progress and timelines are communicated appropriately to the relevant group. Maintain, review and continually develop an effective stock control system. Manage the retention samples including regular inspection. Ensure all procedures are documented and adhered to. Provide scientific and regulatory guidance in the management of stock control and dispensing of materials. Provide innovative solutions and encourage other team members to do the same. 4. Take receipt of returned Clinical Supplies and store appropriately. Manage the destruction of expired and un-required stock for Pharmaceutical Development and as requested for the Clinical Supplies Department. 5. Undertake or assist with the dispatch of materials and products as appropriate by the requesting department. Ensuring shipments are packed, stored, labeled and dispatched under appropriate conditions with supporting documentation available. 6. Develop contacts and establish working relationships with external suppliers to ensure all Pharmaceutical Development materials sourced are of the required quality and are provided in an efficient and timely manner. 7. Work with the appropriate personnel from Pharmaceutical Development and Clinical Supplies in order to plan and ensure continuity of the supply of materials for specified projects and studies. 8. Ensure the maintenance, cleanliness and validation status of laboratory equipment and facilities for Pharmaceutical Development and Clinical Supplies groups are appropriate for the work to be undertaken and in accordance with the Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Standard Operating Procedures (SOPs). 9. Provide supervision and guidance to other team members to ensure that scheduled cleaning and maintenance of equipment is done at the appropriate time. Ensure resources are available as and when required to maintain continuity, compliance and efficiency in the manufacturing activities within the Pharmaceutical Development and Clinical Supplies manufacturing areas. 10. Take responsibility for personal training and development in order to reach and maintain the required level of skills, knowledge and experience to perform the role. Maintain accurate training records. Proactively participate in the company Performance Assessment System, including the agreement of objectives which meet the business requirements and enable personal development and progression. 11. Assist in the recruitment and selection process for new employees within Pharmaceutical Operations as requested by the Head of Department. 12. Assist in budgeting for capital equipment and resources by providing practical and scientific recommendations. 13. Conduct, organise and recommend the training for other team members, in order to maintain and develop the effectiveness of the Department. Ensure individual training records are completed. 14. Ensure all work is undertaken in compliance with the requirements of cGxP (Current Good ‘Clinical, Laboratory, Manufacturing, Pharmaceutical’ Practice), relevant codes of practice (e.g. Medicines Act 1968, EU Directives) and company/departmental SOPs. Ensure compliance with the requirements of Control of Substances Hazardous to Health (COSHH) and Health and Safety at Work Act 1974 (HASAWA). 15. Undertake any other reasonable tasks, to help fulfil the objectives of the Department.